510(k) K100861 ยท HLI Ophthalmoscope, Ac-Powered
R T VUE WITH SOFTWARE 5.0 MODEL: R I VUE 100
| Applicant | Optovue, Inc., Fremont CA, US |
| Decision | Substantially Equivalent, Jun 17, 2010 |
| Received | Mar 26, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K100861
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.